Device for the determination of blood clotting by capacitance or resistance

• US 7,021,122 B1
• Filed: 03/18/1999
• Issued: 04/04/2006
• Est. Priority Date: 03/19/1998
• Status: Expired due to Term

• Current Assignee: Orgenics Biosensors Limited
• Original Assignee: Orgenics Biosensors Limited
• Inventors: Fish, Falk, Rosemberg, Yossef, Levi, Raphael
• Primary Examiner(s): Williams, Hezron
• Assistant Examiner(s): FRANK, RODNEY T
• Application Number:
  US09/646,348
• Time in Patent Office: 2,574 Days
• Field of Search: 732/90.R, 733/04.C, 73/540.1
• US Class Current: 73/54.01
• CPC Class Codes: G01N 11/04 through a restricted passage, e.g. tube, aperture
• CPC Class Codes: G01N 2011/0066 electrical properties
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A sensor device (10) and a method for measuring a viscosity of a sample of a liquid. The sensor features a chamber (12) for receiving the sample of the liquid, two electrodes (18) disposed either on the surfaces of the chamber, but possibly isolated from contacting the sample, or electrodes located externally to the chamber, and a capacitance measuring circuit (25). The sensor is used by connecting to a measurer for determining a capacitance on the electrodes, such that the capacitance directly reflects a volume occupied by the sample of the liquid. Preferably, the liquid is blood and the capacitance is used to determine the clotting time of the blood. Also preferably, a cover for the chamber is provided with at least one aperture, which more preferably is a mesh. Alternatively, an electrical property such as the amplitude of current passed through the sample is used to determine clotting time. Also preferably, the time period required for the maximum capacitance to be reached could be measured. Alternatively, the capacitance could be measured after a fixed time period (34) had elapsed. Also alternatively, the time period required for the maximum current to be reached could be measured, or the amount of current could be measured after a fixed time period had elapsed. In preferred embodiments of the present invention, a kit for measuring the clotting time of blood is provided. In other preferred embodiments of the present invention, methods are provided for using the kit and device of the present invention.

Claims

1. A device for measuring a viscosity of a sample of a liquid, the device consisting essentially of:

(a) a test chamber for receiving a test portion of the sample of the liquid, said test chamber featuring walls for defining an interior space of said test chamber;

(b) a pair of electrodes disposed on said walls of said test chamber

(c) a capacitance measuring circuit for measuring a capacitance of said test portion of the sample within said test chamber between said electrodes, such that said capacitance directly reflects a volume occupied by said test portion of the sample of the liquid; and

(d) a clock for measuring a predetermined time period after said test chamber receives said liquid, such that said amount of said capacitance is determined after said predetermined time period has elapsed.

2. The device of claim 1, further comprising:

(e) an insulator for insulating said pair of electrodes such that said pair of electrodes are prevented from being in contact with the sample of liquid.

3. The device of claim 2, wherein said insulator includes said walls of said test chamber, such that said pair of electrodes is disposed externally to said walls.

4. The device of claim 1, wherein a lower surface of said test chamber has a shape selected from the group consisting of rectangular, square, circular and elliptical.

5. The device of claim 1, further comprising:

(e) a receiver for causing said test chamber to receive said test portion of the sample of the liquid, said receiver being selected from the group consisting of a pump for pumping said test portion into said test chamber and a suction device for creating a vacuum.

6. The device of claim 1, wherein said test portion of the sample of the liquid enters said test chamber from the force selected from the group consisting of gravity, mechanical pressure and osmotic pressure.

7. The device of claim 1, wherein said test portion of the sample of the liquid enters said test chamber from a capillary force induced by a capillary structure of said test chamber.

8. The device of claim 1, wherein said capillary structure is selected from the group consisting of a capillary depth of said test chamber, and a narrow channel shape of said test chamber.

9. The device of claim 1, wherein said test chamber features a single capillary channel.

10. The device of claim 1, wherein the sample of the liquid is selected from the group consisting of whole blood, plasma and serum.

11. The device of claim 10, wherein the sample of the liquid is whole blood.

12. The device of claim 11, wherein a change in the viscosity of said whole blood is caused by coagulation, such that a volume of said test chamber being occupied by said test portion of said whole blood is determined according to said coagulation.

13. The device of claim 12, wherein said test chamber features at least one coagulant agent being in contact with said test portion of said whole blood, said at least one coagulant agent altering a clotting property of said test portion of said whole blood.

14. The device of claim 13, wherein said coagulant agent is an anti-coagulant, such that said test portion of said whole blood clots slower said reference portion of said whole blood.

15. The device of claim 13, wherein said coagulant agent is a pro-coagulation factor, such that said test portion of said whole blood clots faster than said reference portion of said whole blood.

16. The device of claim 13, wherein said at least one coagulant agent is dried onto said test chamber.

17. The device of claim 13, wherein said at least one coagulant agent is a liquid droplet placed onto said test chamber.

18. The device of claim 1, further comprising:

(e) a cover for covering said test chamber, said cover featuring a mesh.

19. The device of claim 1, wherein said clock automatically begins measuring said predetermined time period after said test chamber receives said whole blood.

22. The device of claim 1, further comprising:

(e) a disposable sensor, wherein said test chamber and said electrodes are located on said sensor, such said whole blood is placed on one end of said disposable sensor; and

(f) a sensor receptacle for receiving an opposing end of said disposable sensor such that said electrodes are in electrical contact with said capacitance measurement circuit.

23. The device of claim 22, wherein said disposable sensor is a plastic card.

24. The device of claim 23, wherein said test chamber, said power source, said measure and said disposable sensor are characterized by being suitable for self-operation by a lay person.

25. The device of claim 22, wherein said first and said second pairs of electrodes share a common electrode.

26. The device of claim 22, wherein said at least one pro-coagulating factor is dried onto said disposable sensor.

27. The device of claim 22, wherein said at least one pro-coagulating factor is a liquid droplet placed onto said disposable sensor.

28. The device of claim 22, wherein said clotting time is determined as a prothrombin time.

29. The device of claim 22, wherein said clotting time is determined as a partial prothrombin time.

30. The device of claim 1, wherein said electrodes are constructed from a material selected from the group consisting of carbon, graphite and metal.

31. The device of claim 30, wherein said material is a carbon, graphite or metal impregnated film.

32. The device of claim 30, wherein metal is in a form selected from the group consisting of film, foil, metal impregnated film and metal sputtered film.

33. The device of claim 32, wherein said metal is selected from the group consisting of silver, titanium, stainless steel, palladium, copper and a mixture of silver and silver chloride.

34. The device of claim 1, wherein said electrodes extend along substantially the entirety of said test chamber.

35. The device of claim 1, wherein said electrodes are disposed on opposing sides of said test chamber.

36. The device of claim 1, wherein said electrodes extend along a portion of said test chamber, a length of said portion being shorter than a length of said test chamber.

37. The device of claim 36, wherein said electrodes are disposed on opposing sides of said test chamber and a first electrode of said electrodes is on a side nearer an entrance of said test chamber than a second electrode of said electrodes, such that the viscosity of the sample of liquid is determined by a period of time required for the sample to travel from said first electrode to said second electrode, such that a capacitance is measurable substantially only when the sample occupies substantially all the area located between both said first electrode and said second electrode.

38. The device of claim 1, wherein said chamber features a plurality of surfaces, and said plurality of surfaces is pretreated.

39. The device of claim 38, wherein said pretreated surfaces are pretreated by being soaked in a buffer containing an ingredient selected from the group consisting of a detergent and a hydrophilic polymer.

40. The device of claim 1, further comprising:

(e) a cover for covering said test chamber, said cover featuring at least one aperture.

20. A device for measuring a viscosity of a sample of a liquid, the device consisting essentially of:

(a) a test chamber for receiving a test portion of the sample of the liquid, said test chamber featuring walls for defining an interior space of said test chamber;

(b) a pair of electrodes disposed on said walls of said test chamber;

(c) a capacitance measuring circuit for measuring a capacitance of said test portion of the sample within said test chamber between said electrodes such that said capacitance directly reflects a volume occupied by said test portion of the sample of the liquid; and

(d) a clock for measuring a period of time required for said amount of said capacitance to reach a predetermined level.

21. The device of claim 20, wherein said clock automatically begins measuring said period of time after said test chamber receives said whole blood.